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Recalled Device Costs, Test Payments Focus In OIG Work Plan

 
• By Elizabeth Orr

The Health & Human Services’ watchdog branch plans to look at a spike in recall costs; Medicare’s progress in implementing lab-test payment reforms; and an ongoing review of FDA’s work on device cybersecurity issues.

The 2017 work plan from the US Department of Health & Human Services’ Office of the Inspector General (OIG) reveals plans to further scrutinize the costs of replacing and recalling defective medical devices.

The watchdog plans to review costs “associated with defective medical devices,” such as recall expenses. Recall costs nearly doubled between...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database

 
• By Natasha Barrow

Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.

BD Sees $90M Tariff Hit In Q4; 2026 Impact Reduced To $275M

 
• By Shubham Singh

BD raised its adjusted earnings per share guidance midpoint by $0.18 to a range of $14.30 to $14.45, representing growth of about 9.4% at the midpoint – an increase of approximately 1.4% over prior guidance.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.